FDA Approves Accord BioPharma's IMULDOSA, a Biosimilar to Stelara, for Inflammatory Conditions

Key Insights

• The FDA has approved IMULDOSA (ustekinumab-srlf), a biosimilar developed by Accord BioPharma, for treating chronic inflammatory conditions..
• IMULDOSA is indicated for conditions including psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, expanding treatment options.
• This marks Accord BioPharma's second biosimilar approval in the U.S. following HERCESSI, and the fifth ustekinumab biosimilar to gain FDA approval.

Accord BioPharma announced FDA approval of IMULDOSA (ustekinumab-srlf) on October 14, 2024, a biosimilar to Johnson & Johnson’s STELARA (ustekinumab). IMULDOSA is indicated for the treatment of chronic inflammatory conditions, including psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. This approval marks a significant step in expanding treatment options for these conditions.

IMULDOSA is Accord BioPharma’s second FDA-approved biosimilar product in the United States, following the approval of HERCESSI (trastuzumab-strf) in April 2024. It is also the fifth ustekinumab biosimilar to be approved by the FDA, increasing the availability of this treatment option.

European Regulatory Progress

Just days after the FDA approval, on October 17, 2024, IMULDOSA received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The CHMP recommended that the European Commission grant marketing authorization for IMULDOSA for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease. This positive opinion brings IMULDOSA closer to receiving a European Commission decision, potentially expanding its availability to patients in Europe.